BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GMK-REVISION 02.07.10.8651 TRIAL OFFSET 3MM

    MDR report key: 17441936 · Received August 2, 2023

    Report

    Report Number
    3005180920-2023-00630
    Event Type
    Malfunction
    Date Received
    August 2, 2023
    Date of Event
    July 7, 2023
    Report Date
    November 10, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LXH
    UDI-DI
    07630345713148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PRELIMINARY INVESTIGATION PERFORMED BY R&D MANAGER: FROM THE IMAGE OF THE TRIAL OFFSET THREADED INSERT, IT LOOKS DEFORMED ON THE BOTTOM SIDE. THE INSERT IS FIXED TO THE MAIN BODY OF THE TRIAL OFFSET BY WELDING ON THE UPPER PART AND BY ELASTIC RETENTION SYSTEM ON THE BACK SIDE. WE CAN IMMAGINE THAT THE TWO FIXATION SYSTEMS FAILED DUE TO EXCESSIVE FORCE APPLIED DURING TIBIA KEEL FIXATION BY THE FIXATION SCREW. THE TOOTHED CONNECTION ALLOWS TO FIRMLY LOCK THE TRIAL OFFSET TO THE TIBIA KEEL AND/OR TRIAL FEMUR WITHOUT THE NEED TO TIGHT THE SCREW WITH TOO MUCH FORCE. A VISUAL INSPECTION IS NECESSARY TO BETTER DEFINE THE REASON OF INSTRUMENT FAILURE.

    Additional Manufacturer Narrative · 0

    ANALYSIS PERFORMED BY R&D PROJECT MANAGER: THE PERFORMED ANALYSIS CONFIRMED THAT THE ANTIROTATIONAL INSERT OF THE TRIAL OFFSET HAS BEEN DISASSEMBLED FROM THE MAIN BODY DURING TRIAL REMOVAL FROM THE BONE. DURING EXTRACTION OF THE SYSTEM CONSISTING OF EXTENSION STEM, TRIAL OFFSET AND TRIAL KEEL ASSEMBLY FROM THE BONE, THE ELASTIC CLIPPING OF THE THREADED INSERT OF THE TRIAL OFFSET IS UNABLE TO WITHSTAND THE BLOWS AND DISENGAGES FROM THE OFFSET BODY ITSELF. A NEW MODIFICATION REQUEST (337-23) HAS BEEN OPENED TO IMPROVE THE LOCKING SYSTEM BETWEEN THE TWO COMPONENTS OF THE TRIAL OFFSET. CORRECTION: EVENT DESCRIPTION, DEVICE NOT AVAILABLE, ANALYSIS PERFORMED BY R&D PROJECT MANAGER.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: DEVICE AVAILABLE AND RETURNED ON 24 OCTOBER 2023. VISUAL INSPECTION PERFORMED: VISUAL INSPECTION CONFIRMED THE PRELIMINARY PERFORMED AND CONCLUSIONS OF CASE REPORTED ALSO IN MDR (B)(4). IT HAS BEEN CONFIRMED THAT THE ANTIROTATIONAL INSERT OF THE TRIAL OFFSET HAS BEEN DISASSEMBLED FROM THE MAIN BODY DURING TRIAL REMOVAL FROM THE BONE. BATCH REVIEW PERFORMED ON 12 OCTOBER 2023: LOT 2257626: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-JAN-2023. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED ON THE SAME LOT. CORRECTIONS: LOT CORRECTED WITH 2257626 (CORRECTION OF MANUFACTURING DATE AND BATCH). CORRECTION OF DEVICE AVAILABILY AND DEVICE RETURN DATE. B2 INSERTED OTHER SERIOUS OR IMPORTANT MEDICAL EVENTS. H1 INSERTED MALFUNCTION. H5 INSERTED NO (LABELED FOR SINGLE USE). H6 MEDICAL DEVICE PROBLEM CODE - FRACTURE. H8 INSERTED REUSE.

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON (B)(6), 2023. LOT 2254376: 53 ITEMS MANUFACTURED AND RELEASED ON (B)(6), 2022. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED ON THE SAME LOT. INFORMATION ADDED: - CHANGED DESCRIPTION OF THE EVENT - ADDED THE LOT NUMBER - MANUFACTURER DATE - BATCH REVIEW.

    Description of Event or Problem · 0

    THE TRIAL OFFSET 3MM DETACHED FROM THE TRIAL TIBIAL BASEPLATE DURING SURGERY. THE THREADS INSIDE THE TRIAL OFFSET 3MM CAME OUT. SINCE NO THREADED PART OF THE TRIAL OFFSET REMAINED INSIDE, 40 MINUTES WERE NEEDED TO REMOVE THE TRIAL OFFSET AND THE EXTENSION STEM FROM THE TIBIAL CANAL (TOTAL SURGERY TIME OF 2 ½ HOURS). SURGERY COMPLETED SUCCESSFULLY.

    Description of Event or Problem · 0

    THE TRIAL OFFSET 3MM DETACHED FROM THE TRIAL TIBIAL BASEPLATE (REF: 02.07.10.3939, LOT: 2163090) DURING SURGERY. THE ANTIROTATIONAL INSERT OF THE TRIAL OFFSET 3MM CAME OUT. SINCE NO THREADED PART OF THE TRIAL OFFSET REMAINED INSIDE, 40 MINUTES WERE NEEDED TO REMOVE THE TRIAL OFFSET AND THE EXTENSION STEM FROM THE TIBIAL CANAL (TOTAL SURGERY TIME OF 2 ½ HOURS). SURGERY COMPLETED SUCCESSFULLY.

    Description of Event or Problem · 0

    THE TRIAL OFFSET 3MM DETACHED FROM THE TRIAL TIBIAL BASEPLATE (REF 02.07.10.3939 LOT 2163090) DURING SURGERY. THE THREADS INSIDE THE TRIAL OFFSET 3MM CAME OUT. SINCE NO THREADED PART OF THE TRIAL OFFSET REMAINED INSIDE, 40 MINUTES WERE NEEDED TO REMOVE THE TRIAL OFFSET AND THE EXTENSION STEM FROM THE TIBIAL CANAL (TOTAL SURGERY TIME OF 2 ½ HOURS). SURGERY COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1261034 GMK-REVISION 02.07.10.8651 TRIAL OFFSET 3MM SURGICAL INSTRUMENT FOR KNEE SURGERY LXH MEDACTA INTERNATIONAL SA 2257626 07630345713148

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other